Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Region Skane
Sponsor:
Collaborators:
Göteborg University
Uppsala University Hospital
Karolinska University Hospital
University Hospital, Linkoeping
University Hospital, Umeå
University Hospital Orebro
Information provided by (Responsible Party):
Emma Nilsson, Region Skane
ClinicalTrials.gov Identifier:
NCT01801228
First received: February 26, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.


Condition Intervention Phase
Ascites
Cirrhosis
Drug: Eplerenone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Ascites [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenone
oral daily treatment with doses 100 to 400 mg
Drug: Eplerenone
Active Comparator: Spironolactone
oral daily treatment with doses 100 to 400 mg
Drug: Eplerenone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male Ascites Cirrhosis

-

Exclusion Criteria:

Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801228

Contacts
Contact: Emma Nilsson, MD +4646177706 emma.nilsson@skane.se

Locations
Sweden
University Hospital of Skane Recruiting
Lund, Skane, Sweden, 221 85
Principal Investigator: Emma Nilsson, MD         
University Hospital of Skane Active, not recruiting
Lund, Skane, Sweden, 221 85
Sponsors and Collaborators
Emma Nilsson
Göteborg University
Uppsala University Hospital
Karolinska University Hospital
University Hospital, Linkoeping
University Hospital, Umeå
University Hospital Orebro
  More Information

No publications provided

Responsible Party: Emma Nilsson, Gastroenterologist, Region Skane
ClinicalTrials.gov Identifier: NCT01801228     History of Changes
Other Study ID Numbers: 2011-001264-22, 2011-001264-22
Study First Received: February 26, 2013
Last Updated: February 27, 2013
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Spironolactone
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014